Study Selection, Quality Assessment & Data Extraction Form
First author
Journal/Conference
Proceedings etc
Year
Study eligibility
RCT/Quasi/CCT
(delete
Relevant participants
Relevant interventions
Relevant outcomes
Yes / No / Unclear
Yes / No / Unclear
Yes / No* / Unclear
as appropriate)
Yes / No / Unclear
* Issue relates to selective reporting – when authors may have taken measurements for particular outcomes, but not reported
these within the paper(s). Reviewers should contact trialists for information on possible non-reported outcomes & reasons for
exclusion from publication. Study should be listed in ‘Studies awaiting assessment’ until clarified. If no clarification is
received after three attempts, study should then be excluded.
Do not proceed if any of the above answers are ‘No’. If study to be included in ‘Excluded studies’
section of the review, record below the information to be inserted into ‘Table of excluded studies’.
References to trial
Check other references identified in searches. If there are further references to this trial link the
papers now & list below. All references to a trial should be linked under one Study ID in RevMan.
Code
each
paper
Author(s)
A
The paper listed above
B
Further papers
Journal/Conference
Proceedings etc
Year
Cochrane CFGD February 2009
1
Participants and trial characteristics
Participant characteristics
Further details
Age (mean, median, range, etc)
Sex of participants (numbers / %, etc)
Disease status / type, etc
(if applicable)
Other
Trial characteristics
see Appendix 1, usually just completed by one reviewer
Risk of bias
We recommend you refer to and use the method described in the Cochrane Reviewers’ Handbook,
Version 5.1*
Allocation of intervention
State here method used to generate allocation and reasons for grading
Risk of bias (circle)
Low (Random)
High (e.g. alternate)
Unclear
Concealment of allocation
Process used to prevent foreknowledge of group assignment in a RCT, which should be seen as distinct from blinding
State here method used to conceal allocation and reasons for grading
Risk of bias (circle)
Low
High
Unclear
Blinding
Person responsible for participants care
Yes / No
Participant
Yes / No
Outcome assessor
Yes / No
Other (please specify)
Yes / No
Cochrane CFGD February 2009
2
Intention-to-treat
An intention-to-treat analysis is one in which all the participants in a trial are analysed according to the intervention to which they were
allocated, whether they received it or not.
All participants entering trial
15% or fewer excluded
More than 15% excluded
Not analysed as ‘intention-to-treat’
Unclear
Were withdrawals described? Yes 
No 
not clear 
Discuss if appropriate…………………………………………………………………………………………
…………………………………………………………………………………………………………
Selective outcome reporting
Have you been able to access the trial protocol?
Are all outcomes listed in protocol reported in
the full trial paper?
Data extraction
Outcomes relevant to your review
Copy and paste from ‘Types of outcome measures’
Reported in paper (circle)
Outcome 1
Yes / No
Outcome 2
Yes / No
Outcome 3
Yes / No
Outcome 4
Yes / No
Outcome 5
Yes / No
Outcome 6
Yes / No
Outcome 7
Yes / No
Outcome 8
Yes / No
Cochrane CFGD February 2009
3
For Continuous data
Code
of
paper
A etc
Outcomes (rename)
Unit of
measurement
Intervention group
n
Mean (SD)
Control group
n
Details if outcome only described in text
Mean (SD)
Outcome A
Outcome B
Outcome C
Outcome D
Outcome E
Outcome F
Cochrane CFGD February 2009
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For Dichotomous data
Code of
paper
A
Outcomes (rename)
Intervention group (n)
Control group (n)
n = number of participants, not number of
events
n = number of participants, not number of
events
Outcome G
Outcome H
Outcome I
Outcome J
Outcome K
Outcome L
Other information which you feel is relevant to the results
Indicate if: any data were obtained from the primary author; if results were estimated from graphs
etc; or calculated by you using a formula (this should be stated and the formula given). In general if
results not reported in paper(s) are obtained this should be made clear here to be cited in review.
References to other trials
Did this report include any references to published reports of potentially eligible trials not already
identified for this review?
First author
Journal / Conference
Year of publication
Did this report include any references to unpublished data from potentially eligible trials not
already identified for this review? If yes, give list contact name and details
Cochrane CFGD February 2009
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Appendix 1
Trial characteristics
Further details
Single centre / multicentre
Country / Countries
How was participant eligibility defined?
How many people were randomised?
Number of participants in each intervention
group
Number of participants who received intended
treatment
Number of participants who were analysed
Drug treatment(s) used
Dose / frequency of administration
Duration of treatment
(State weeks / months, etc, if crossover trial give length of time in each arm)
Median (range) length of follow-up reported in
this paper (state weeks, months or years or if not stated)
Time-points when measurements were taken
during the study
Time-points reported in the study
Time-points you are using in Meta-View
Trial design
(e.g. parallel / cross-over*)
Other
* If cross-over design, please refer to the Cochrane Editorial Office for further advice on how to analyse these data
References
Cochrane Reviewers’ Handbook, Version 5.1
Higgins JPT, Green S (editors). Cochrane Handbook for Systematic Reviews of Interventions
Version 5.1 [updated March 2011]. The Cochrane Collaboration, 2011. Available from
www.cochrane-handbook.org.
Cochrane CFGD February 2009
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